December 6, 2016
By Alex Keown, BioSpace.com Breaking News Staff
NEW YORK – Investors should pay close attention as the calendar winds down on 2016. Several companies are planning to present data or engage in programs that could impact stock prices. The news site 24/7 Wall Street gathered 10 catalysts expected in the last few weeks of December.
Dynavax Technologies Corporation
Berkley, Calif.-based Dynavax Technologies Corporation will meet with the U.S. Food and Drug Administration on Dec. 15 for its Heplisav-B drug, used to treat hepatitis B. The company is scheduled to have its Prescription Drug User Fee Act meeting with the regulatory agency that day. In November, the FDA rejected the company’s bid for approval of Heplisav-B. The FDA sent the company a Complete Response Letter saying the regulatory agency is seeking additional information before it can move forward in the approval process. They said it needed more time to review the data and those clarifications must be made before the FDA will clear Heplisav-B. Shares of Dynavax plunged after the FDA rejected the drug on Nov. 30, but the stock has been on the recovery track. Shares are trading at $5 as of 10:22 a.m.
Repros will participate as a sponsor in a public advisory committee meeting of the FDA’s Bone, Reproductive and Urologic Drugs Advisory Committee, the news site reported. During the meeting, set for Dec. 6, participants will provide advice and recommendations to the FDA on the FDA’s regulatory issues.
The FDA is set to make a decision on Spectrum ’s bladder cancer drug qapzola (apaziquone) on Dec. 11. In September, an advisory panel rejected the data—something the company may have been aware of for some time. In September, The Street’s Adam Feuerstein reported that Spectrum was told by regulators not to seek submission in 2012. That means that for at least three years, the company concealed information about the drug’s lack of a chance of approval.
Phase III data for a second trial with sotagliflozin, a dual inhibitor of sodium-glucose transporters 1 and 2 (SGLT-1 and SGLT-2), is expected to be released near the end of the month. In September, Lexicon released data on the first Phase III Type 1 diabetes trial trial with sotagliflozin. Data from that trial showed the drug met its primary endpoint, showing significant improvement in blood sugar control. Lexicon is developing sotagliflozin along with Sanofi. The two companies struck a $1.7 billion deal in November 2015, which gave the French company exclusive marketing rights to sotagliflozin.
On Dec. 6, the company is hosting its R&D Day. During the event analysts are expecting the company to announce new product candidates as well as provide an overview of the company’s pipeline, 24/7 Wall Street said.
The company is expected to release Phase I data for INT-767, the company’s second bile acid analog to enter clinical development. Intercept is also expecting the European Medicines Agency to approve its drug Ocaliva for primary biliary cholangitis. Ocaliva was approved by the FDA in May and analysts suggest Ocaliva could bring in sales of $1.6 billion by 2020—especially if the drug could be expanded to the NASH market. Intercept spent much of the early part of 2016 being talked about as a potential takeover target by companies such as Gilead Sciences and AstraZeneca .
Omeros Corp, Pacira Pharmaceuticals, Ascendis Pharma A/S, XOMA Corp
Other possible catalysts in the month of December include a possible pipeline or partnership announcement by Omeros Corp and a potential partnership announcement by Pacira Pharmaceuticals, 24/7 Wall Street said. Another partnership could be announced by Ascendis Pharma A/S. Bay Area-based Xoma Corp. is expecting a milestone payment and could announce a licensing agreement this month as well, according to the report.
